Metronidazole 500mg/100ml Inj,100ml
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on what to do next.
Lifestyle & Tips
- **Avoid alcohol completely** during treatment and for at least 3 days after stopping metronidazole. Drinking alcohol can cause severe nausea, vomiting, flushing, headache, and stomach cramps (a disulfiram-like reaction). This includes alcohol in medications, mouthwashes, and other products.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any unusual numbness, tingling, pain, or weakness in your hands or feet to your doctor immediately.
- Report any signs of confusion, seizures, or vision changes to your doctor immediately.
- This medication may cause your urine to turn a dark or reddish-brown color, which is harmless.
Available Forms & Alternatives
Available Strengths:
- Metronidazole 0.75% Topical Crm 45g
- Metronidazole 250mg Tablets
- Metronidazole 0.75% Topical Lotion
- Metron/nacl 500mg Pb Inj, 100ml
- Metronidazole 0.75% Vaginal Gel 70g
- Metronidazole 500mg Tablets
- Metronidazole 0.75% Topical Crm 45g
- Metronidazole 0.75% Topical Gel 45g
- Metronidazole 375mg Capsules
- Metronidazole 500mg Tablets
- Metronidazole 250mg Tablets
- Metronidazole 1% Topical Gel Pump
- Metronidazole 1% Topical Gel Tube
- Metronidazole 500mg/100ml Inj,100ml
- Metronidazole 0.75% Vaginal Gel 70g
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Redness or white patches in the mouth or throat
Vaginal itching or discharge
Abnormal or rapid heartbeat
Painful urination or blood in the urine
Frequent urination
Pelvic pain
Ringing in the ears, hearing loss, or other changes in hearing
Nervous system problems, including:
+ Burning, numbness, or tingling sensations
+ Changes in balance or vision
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Mood changes, such as:
+ Confusion
+ Depression
+ Irritability
+ Fatigue
+ Weakness
Symptoms of aseptic meningitis, including:
+ Headache
+ Fever
+ Chills
+ Nausea or vomiting
+ Stiff neck
+ Rash
+ Sensitivity to light
+ Drowsiness
+ Confusion
Signs of infection, such as:
+ Fever
+ Chills
+ Sore throat
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect internal organs
+ Symptoms include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects, contact your doctor if they bother you or do not resolve on their own:
Gastrointestinal symptoms, such as:
+ Constipation
+ Diarrhea
+ Stomach pain
+ Nausea or vomiting
+ Decreased appetite
Stomach cramps
Metallic taste
Headache
Joint pain
Decreased libido
Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Severe headache
- Dizziness or lightheadedness
- Numbness, tingling, or pain in hands or feet (peripheral neuropathy)
- Seizures
- Confusion or hallucinations
- Vision changes (e.g., double vision, blurred vision)
- Rash, itching, or hives
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Severe diarrhea (especially if watery or bloody)
- Unusual bleeding or bruising
- Yellowing of the skin or eyes (jaundice)
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have Cockayne syndrome, as some individuals with this condition have experienced liver problems while taking this medication. In some cases, these liver issues have been severe, persistent, or even fatal.
If you have taken disulfiram within the past 14 days.
If you are less than 12 weeks pregnant, as this medication is not intended for use during this period.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you are undergoing dialysis, consult with your doctor to discuss any necessary precautions.
To minimize potential interactions, you may need to avoid consuming alcohol or products containing alcohol or propylene glycol during treatment with this medication and for at least 72 hours after your last dose. Examples of products that may contain alcohol or propylene glycol include some cough syrups. Consuming these substances may cause adverse effects such as stomach cramps, nausea, vomiting, headaches, and flushing. Consult with your doctor to determine if you need to avoid alcohol or products containing alcohol or propylene glycol.
Do not take this medication for longer than prescribed, as this may increase the risk of a second infection. If you are following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor to ensure informed decision-making.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Ataxia (loss of coordination)
- Disorientation
- Seizures
- Peripheral neuropathy (with prolonged high doses)
What to Do:
There is no specific antidote for metronidazole overdose. Treatment is symptomatic and supportive. Gastric lavage may be considered if ingestion was recent. Hemodialysis can remove metronidazole and its metabolites. Call 1-800-222-1222 (Poison Control Center) immediately for advice.
Drug Interactions
Contraindicated Interactions
- Alcohol (including propylene glycol-containing products) - disulfiram-like reaction
- Disulfiram (within 2 weeks) - psychotic reactions
Major Interactions
- Warfarin and other oral anticoagulants (increased anticoagulant effect)
- Lithium (increased lithium levels and toxicity)
- Busulfan (increased busulfan toxicity)
- Phenytoin, Phenobarbital (decreased metronidazole levels, increased phenytoin levels)
- Cimetidine (increased metronidazole levels)
Moderate Interactions
- Fluorouracil (increased fluorouracil toxicity)
- Cyclosporine (increased cyclosporine levels)
- Tacrolimus (increased tacrolimus levels)
- Oral contraceptives (potential for reduced efficacy, though clinical significance debated)
Minor Interactions
- Cholestyramine (decreased metronidazole absorption if oral formulation used)
Monitoring
Baseline Monitoring
Rationale: To assess baseline hepatic function, especially in patients with known or suspected liver impairment, as metronidazole is metabolized in the liver.
Timing: Prior to initiation of therapy
Rationale: To assess baseline renal function, though dose adjustment is generally not needed for mild-moderate impairment, it's important for severe impairment and dialysis patients.
Timing: Prior to initiation of therapy
Rationale: To establish baseline hematologic status, as metronidazole can rarely cause neutropenia or leukopenia.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Daily, especially with prolonged therapy (>10 days)
Target: Absence of symptoms
Action Threshold: If symptoms develop, consider discontinuing metronidazole or reducing dose.
Frequency: Daily
Target: Absence of symptoms
Action Threshold: If symptoms develop, discontinue metronidazole immediately.
Frequency: More frequently (e.g., daily to every few days) during co-administration and for several days after metronidazole discontinuation.
Target: Therapeutic range for indication
Action Threshold: Adjust warfarin dose to maintain target INR; anticipate significant increase in INR.
Frequency: More frequently (e.g., 2-3 times per week) during co-administration.
Target: Therapeutic range for indication
Action Threshold: Adjust lithium dose to maintain target levels; monitor for signs of lithium toxicity.
Frequency: Periodically (e.g., weekly) during prolonged therapy
Target: Within normal limits
Action Threshold: If significant neutropenia or leukopenia develops, consider discontinuing metronidazole.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Metallic taste
- Headache
- Dizziness
- Peripheral neuropathy (numbness, tingling, weakness)
- Seizures
- Encephalopathy
- Aseptic meningitis
- Rash
- Darkening of urine
Special Patient Groups
Pregnancy
Metronidazole crosses the placenta. While animal studies show some evidence of carcinogenicity, human data from controlled studies and meta-analyses have not shown an increased risk of birth defects or other adverse outcomes when used during the second and third trimesters. Use in the first trimester is generally avoided if possible, but may be considered if clearly needed and benefits outweigh risks.
Trimester-Specific Risks:
Lactation
Metronidazole is excreted into breast milk in concentrations similar to maternal plasma. Due to the potential for serious adverse reactions, including carcinogenicity (based on animal data), in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If a single high dose is given, breastfeeding can be interrupted for 12-24 hours.
Pediatric Use
Metronidazole is used in pediatric patients for various anaerobic and protozoal infections. Dosing is weight-based. Neonates and infants may have reduced clearance, requiring careful monitoring and dose adjustment. Safety and efficacy in very low birth weight infants have not been fully established.
Geriatric Use
No specific dose adjustment is generally required based solely on age. However, elderly patients are more likely to have decreased hepatic function, which may necessitate dose reduction in severe impairment. Monitor for adverse effects, especially neurological ones, as elderly patients may be more susceptible.
Clinical Information
Clinical Pearls
- Metronidazole is a potent anaerobic and antiprotozoal agent, but it has no activity against aerobic bacteria.
- The disulfiram-like reaction with alcohol is severe and patients must be counselled rigorously to avoid all alcohol-containing products during and for at least 3 days after therapy.
- Prolonged or high-dose therapy can lead to peripheral neuropathy or CNS toxicity (e.g., seizures, encephalopathy). Monitor for these symptoms and discontinue if they occur.
- Metronidazole can significantly potentiate the effect of warfarin, requiring frequent INR monitoring and dose adjustments.
- IV metronidazole should be infused slowly over 30-60 minutes to minimize infusion-related reactions.
- Urine discoloration (darkening) is a common and harmless side effect.
Alternative Therapies
- Clindamycin (for anaerobic infections, but less effective against some protozoa)
- Tigecycline (broad-spectrum, including anaerobes)
- Carbapenems (e.g., Imipenem, Meropenem, Ertapenem - broad-spectrum, including anaerobes)
- Tinidazole (another nitroimidazole, similar spectrum, longer half-life)
- Oral Vancomycin or Fidaxomicin (for C. difficile infection, where metronidazole is also used)